FDA Approves Biktarvy to Treat HIV-1 Infection in Adults

Biktarvy is a three-drug fixed dose combination product
Biktarvy is a three-drug fixed dose combination product

The Food and Drug Administration (FDA) has approved Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide; Gilead) for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

Biktarvy combines bictegravir, an integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), two nucleoside reverse transcriptase inhibitors (NRTIs). 

Biktarvy was evaluated in multiple clinical trials involving HIV-1 adults with no antiretroviral treatment history (Studies 1489 and 1490) or those who were virologically suppressed (Studies 1844 and 1878).

In Study 1489, treatment-naïve patients (n=629) were randomized to receive Biktarvy or abacavir/dolutegravir/lamivudine (600/50/300mg) (ABC/DTG/3TC). At Week 48, 92.4% of Biktarvy patients and 93.0% of ABC/DTG/3TC patients met the primary endpoint of HIV-1 RNA <50 copies/mL. 

In Study 1490, treatment-naïve patients (n=645) were randomized to receive Biktarvy or DTG+FTC/TAF. At Week 48, 89.4% of Biktarvy patients and 92.9% of DTG+FTC/TAF patients met the primary endpoint of HIV-1 RNA <50 copies/mL. 

In Study 1878, virologically suppressed patients (n=577) were randomized to either continue their boosted protease inhibitor (bPI) regimen or to switch to open-label coformulated Biktarvy once daily. At Week 48, switching to Biktarvy was non-inferior to continuing on a bPI regimen with 92.1% of Biktarvy-treated patients and 88.9% of bPI-treated patients achieving HIV-1 RNA <50 copies/mL. 

Data from Study 1844 will be announced at a future scientific conference. 

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Across all 4 trials, there were no reports of treatment failure with Biktarvy; none of the study patients discontinued treatment due to renal adverse events. Diarrhea, nausea, and headache were the most commonly reported adverse reactions. 

Biktarvy is available as 50mg/200mg/25mg fixed-dose tablets in 30-count bottles. 

For more information call (800) 445-3235 or visit Gilead.com.